Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
600
Participants Needed
169
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating nipocalimab compared to placebo in adults with moderate to severe Systemic Lupus Erythematosus SLE, a chronic condition where the immune system attacks healthy tissues causing inflammation in various organs. This Phase 3 study aims to measure how well nipocalimab works using the SLE Responder Index SRI-4 response at Week 52 as the primary outcome. Participants will be randomly assigned to receive either nipocalimab or placebo along with standard care treatments during a 52-week double-blind period. After Week 52, eligible participants from both groups can join an open-label extension where they will receive nipocalimab until Week 156 or until the treatment is stopped. Throughout the study, participants will have regular assessments including physical exams, medical history reviews, vital signs, ECGs, and disease activity scoring. Researchers will track responses such as disease activity, joint pain, fatigue, and flare status at Week 52. Safety monitoring will continue during the extension period, with total participation lasting up to about three years.
CONDITIONS
Brief Title
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically stable based on physical exam, medical history, vital signs, and ECG at screening
- Clinical diagnosis of systemic lupus erythematosus (SLE) for at least 24 weeks using EULAR/ACR criteria
- SLEDAI-2K score of 6 or higher and clinical SLEDAI-2K score of 4 or higher at screening and Week 0, excluding lupus headache, alopecia, and organic brain syndrome
- Negative serum beta hCG test at screening and negative urine beta hCG test at Week 0 for women of childbearing potential
- At least 1 BILAG-2004 A score or 2 BILAG-2004 B scores at screening
You will not qualify if you...
- History of severe, progressive, or uncontrolled disorders affecting liver, gastrointestinal, kidney, lung, heart, psychiatric, neurological, musculoskeletal systems, hypertension, or other uncontrolled autoimmune diseases
- Unstable or progressive SLE likely requiring therapy escalation beyond allowed background medications
- Confirmed or suspected immunodeficiency not related to SLE treatment, or family history of congenital immunodeficiency unless confirmed absent
- Previous severe immediate hypersensitivity reaction such as anaphylaxis to therapeutic proteins
- Known or suspected allergies or intolerance to nipocalimab, its excipients, or placebo excipients
Research Team
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Study Contact
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